BAYCOL (nda020740)- (0.05MG,0.1MG,0.2MG,0.3MG,0.4MG,0.8MG)

Generic Name	CERIVASTATIN SODIUM	Innovator	BAYER PHARMS
Dosage	0.05MG,0.1MG,0.2MG,0.3MG,0.4MG,0.8MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2011-Nov-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BAYCOL® (cerivastatin sodium tablets) is indicated as an adjunct to diet to reduce elevated Total-C, LDLC, apo B, and TG and to increase HDL-C levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.05MG	**	**	-	-	-
0.1MG	**	**	-	-	-
0.2MG	**	**	-	-	-
0.3MG	**	**	-	-	-
0.4MG	**	**	-	-	-
0.8MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of BAYCOL